Aortic & peripheral vascular disease
Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial
Authors' conclusion
Neither DCBA±BMS nor DES conferred significant clinical benefit over PBA±BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.
Study context
- Population
- Patients with chronic limb threatening ischaemia requiring endovascular femoro-popliteal, with or without infra-popliteal, revascularisationrandomised 2016–2021
- Participants
- 481 patients
- Comparison
- DCBA±BMS or drug eluting stenting (DES) vs PBA±BMS for femoro-popliteal revascularisation
- PBA±BMSn = 160reference
- DCBA±BMSn = 161
- DESn = 159
- Primary endpoint
- Amputation free survival (time to first major amputation or death from any cause)
Methodological detailsthree arm, open label, pragmatic, multicentre, phase 3 superiority, 35 UK NHS vascular units
- Three arm
- Open label
- Pragmatic
- Multicentre
- Phase 3 superiority
- 35 UK NHS vascular units
Primary result
As reported in the abstract
Major amputation or death
Adjusted hazard ratio (97.5% CI)P value
PBA±BMS vs DCBA±BMS
0.84(0.61–1.16)
P = 0.22PBA±BMS vs DES
0.83(0.60–1.15)
P = 0.20Safety
Serious adverse events up to 30 days after first revascularisation
- No differences in serious adverse events between the groups
Original publication
Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial. BMJ. Published 24 February 2025. doi:10.
Summarised from the published abstract; every number is checked against it